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WO1987006144A1 - Systeme therapeutique planiforme, son procede de fabrication et son utilisation - Google Patents

Systeme therapeutique planiforme, son procede de fabrication et son utilisation Download PDF

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Publication number
WO1987006144A1
WO1987006144A1 PCT/DE1987/000174 DE8700174W WO8706144A1 WO 1987006144 A1 WO1987006144 A1 WO 1987006144A1 DE 8700174 W DE8700174 W DE 8700174W WO 8706144 A1 WO8706144 A1 WO 8706144A1
Authority
WO
WIPO (PCT)
Prior art keywords
therapeutic system
layer
sheet
skin
active substance
Prior art date
Application number
PCT/DE1987/000174
Other languages
German (de)
English (en)
Inventor
Karin Wolter
Fritz Herrmann
Hans Rainer Hoffmann
Günter Simon
Thomas Kissel
Joerg Reinhardt
Original Assignee
Lohmann Gmbh & Co. Kg.
Sandoz Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lohmann Gmbh & Co. Kg., Sandoz Ag filed Critical Lohmann Gmbh & Co. Kg.
Priority to HU872359A priority Critical patent/HU203842B/hu
Priority to KR1019870701189A priority patent/KR900007178B1/ko
Publication of WO1987006144A1 publication Critical patent/WO1987006144A1/fr
Priority to NO875144A priority patent/NO171951C/no
Priority to DK662887A priority patent/DK170434B1/da

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
    • A45D34/00—Containers or accessories specially adapted for handling liquid toiletry or cosmetic substances, e.g. perfumes
    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
    • A45D44/00—Other cosmetic or toiletry articles, e.g. for hairdressers' rooms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0208—Tissues; Wipes; Patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7092—Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the invention relates to a sheet-like therapeutic system for the administration of active substances to the skin, with active substance reservoir (s) with active substance delivery surfaces and with pressure sensitive adhesive areas arranged on the skin side; a method for producing the sheet-like, therapeutic 'system ⁇ and its use.
  • the invention thus relates to a * transdermal therapeutic system for the administration of medicinally active substances or also cosmetically active substances to human or animal skin.
  • a therapeutic system is a device or a form of administration containing drugs or active ingredients, which delivers one or more active ingredients at a predetermined rate continuously over a specified period of time at a specified application location.
  • a common structure of such a transdermal therapeutic system is a drug reservoir in which the active ingredient is in solid, liquid or dissolved form and a pressure-sensitive adhesion layer through which the system is closely bonded to the skin.
  • This principle has its limits where the active ingredient does not diffuse through the pressure-sensitive adhesive layer or a chemical reaction occurs between the active ingredient and the pressure-sensitive adhesive, or where the active ingredient is not or only poorly soluble in the pressure-sensitive adhesive.
  • attempts have been made to bring a non-pressure-sensitive active substance-containing reservoir or the active substance itself into direct contact with the skin and to fix this reservoir or the active substance itself to the skin by additional measures.
  • Separate ones are suitable for this, for example pressure-sensitive adhesive strips or the integration of the reservoir or the active substance in a plaster such that the reservoir or the active substance is surrounded all around by a pressure-sensitive edge (see, for example, DE-OS 29 02 183). If the contact area exceeds a certain size, the constant contact with the skin necessary for the controlled therapy is no longer guaranteed due to the unavoidable body and muscle movements with prolonged wearing time, which is known to be days or even weeks.
  • the object is achieved in a generic sheet-like therapeutic system in that the active ingredient delivery area section (s) to be brought into contact with the skin are at the same level.
  • the system according to the invention is particularly advantageous for the administration of active substances which react unfavorably with pressure-sensitive adhesive substances or which do not diffuse through a skin-adhesive layer.
  • the active substance delivery surface sections are distributed uniformly or unevenly in the skin contact surface. It can be particularly advantageous if the active fabric release surface sections are round or angular. Skin adhesion surface sections can be distributed regularly or irregularly in the skin contact surface. The skin adhesion surface sections can be round or angular. However, it can also be particularly preferred for certain application forms that skin adhesion and active substance delivery surface sections are arranged alternately in strips. In a particularly preferred embodiment of the invention, the skin contact surface can have a circumferential skin adhesion edge.
  • the system according to the invention can furthermore have a flexible backing layer facing away from the skin and optionally a removable protective layer. In addition, to improve the mechanical stability, it can have an opening supporting layer.
  • the support layer can essentially consist of paper, a textile fabric, a metal or a plastic film or laminates thereof.
  • a pressure-sensitive adhesive layer may be present in whole or in part between the support layer and the active substance reservoir.
  • the drug reservoir can have one or more drugs with topical or systemic action,
  • the active ingredient (s) is preferably selected from the group of cardiac glycosides from Digitalis lanata- ⁇ -acetyldigoxin; Vasodilate furnace, for example pentaerithrityl tetranitrate, cinnarizine or nitroglycerin, the musculotropic antispasmodics, for example moxaverin HC1; Coronary therapeutic agents, for example oxyfedrine HC1, coronary dilators, for example N- (3,3-diphenylpropyl) alpha-methyl-benzylamine HC1 (fendiline); Antihistamines such as clemastine or antiemeticum dimethhydrinate, analeptics such as caffeine; Analgesics such as phenazone chloral hydrate; Hypnotics, such as chlorobutanol, musculotropic vasodilators, such as nicotinic acid, vitamin B ⁇ , such as pyridoxine, broncholytic
  • Preferred active ingredients are amphetaminil, bethahistine, beta-acetyldigoxin, bopindolol, buprenorphine, clemastine, diclo enac, diltiazen, dimenhydrinate, diethylamine salicylic, ethylene glycol monosalicylate, 5-fluorouracil, glibenclide, hydromorpho, 4-propyl, ibuprofen 1,3-benzoxadiazol-4-yl) -1,4-dihydro-5-methoxycarbonyl-2,6-dimethyl-3-pyridine-carboxy-lat, ketotifen, L-thyroxine, nicotin, nicotinic acid-butoxyethyl ester , Nonyläurevanillyla-, mid, pindolol, salbutamol, 'tamoxifen, tizanidine, and their bases, salts and derivatives.
  • the active ingredients can also
  • a .. vasodilator e.g. Pentaerithrityl tetranitrate or nitroglycerin
  • a musculotropic spasmolyticum e.g. B. Moxaverin HC1 -3.
  • a Coronartherapeuticum e.g. Oxyfedrine HC1 or -4.
  • a coronary dilator e.g. N- (3.3-diphenylpropyl) -
  • Vasodilator Ant-Lhistaminicum, e.g. Cinnarizine,
  • Analeptic e.g. Caffeine
  • Theophylline compounds such as:
  • Theophylline derivatives such as:
  • E. Rubefazientes such as nicotinic acid- ⁇ -butoxyethyl ester and / or nonyl acid vanillylamide - in combination with an anti-inflammatory agent, e.g. Ethylene glycol monosalicylate or diethylamine salicylate.
  • an anti-inflammatory agent e.g. Ethylene glycol monosalicylate or diethylamine salicylate.
  • a particular advantage that can be achieved by such active substance combinations is that ideally several Active substances can be administered simultaneously, if necessary with different delivery speeds, which cannot be processed or stored in a mixture - be it because of reactions with one another or different physical properties.
  • the manufacturing steps explained later allow problem-free separate incorporation of the active ingredients.
  • compositions according to the invention are:
  • Ampheta inil Bethahistin, ß-acetyldigoxin, bopindolol, butprenorphin, clemastine, diclofenac, diltiazen, dimenhydrinate, diethylamine salicylate, ethylene glycol monosalicylate, 5-fluorouracil, glibenclamide, hydromorphone, isopropyl, (2,1), ibuprofen (2,1 3-benzoxadiazol-4-yl) -l, 4-dihydro-5-meth-oxy-carbonyl-2, ⁇ -dimethyl-3-pyridine-carboxylate, ketotifen, L-thyroxine, nicotine, nicotinic acid- ⁇ -butoxyethyl ester, nonyl acid vanillylamide , Pindolol, salbutamol, tamoxifen, tizanidine, theophylline, and the bases, salts and derivatives of the a
  • the invention also relates to methods for producing the sheet-like therapeutic system, which has the following steps:
  • skin adhesion sections are applied to a protective layer underlay, these skin adhesion layer sections and the protective layer underlates are coated with an active substance-containing reservoir mass, a backing layer, optionally with a pressure-sensitive adhesive, is laminated on, and the finished system is assembled
  • the invention also relates to the use of the system for local or systemic transdermal drug delivery in human or veterinary medicine or cosmetics. • * •
  • the therapeutically required active substance delivery surfaces lie alternately with pressure-sensitive adhesive surfaces in one plane, allows satisfactory, long-lasting intimate contacting of the active substance delivery reservoir with the skin surface receiving the active substance, whereby the continuous active substance alone is added ⁇ is guaranteed, as is therapeutically desirable.
  • FIG. 1 shows schematically the skin contact surface of a section of a sheet-like therapeutic system according to the invention
  • FIG. 2 shows a cross section along line II of FIG. 1 on an enlarged scale
  • FIG. 3 shows a section of the skin contact surface of a further preferred embodiment of the invention.
  • Fig. 4 schematically enlarges the cross section along line II-II of Fig. 3;
  • the skin contact layer is subdivided according to two basic principles:
  • the drug delivery areas are distributed individually in a skin adhesion area, which may also contain the drug.
  • An active ingredient delivery surface is interrupted by a skin adhesion surface which may also contain an active ingredient.
  • Embodiments of the invention according to principle A are shown in Figures 1, 2 and 6; while FIGS. 3, 4 and 5 show embodiments which correspond to principle B.
  • FIGS. 1 and 2 circular active substance delivery surfaces 2 are symmetrically distributed in a pressure-sensitive skin adhesion surface 1.
  • this embodiment is only to be taken as an example and is not to be seen as limiting the idea of the invention, since the arrangement of the active substance delivery surfaces, their size, their geometric shape and their distance from one another are variable and depend on the therapeutic and physical requirements.
  • FIG. 2 shows the section along the line I-I in FIG. 1.
  • a pressure-sensitive adhesive layer 4 is arranged under a backing layer 3, which ensures the cohesion with an active substance reservoir layer 5.
  • the reservoir layer 5 is overlaid by a perforated support layer ⁇ which has a skin adhesion layer 1 on the skin side.
  • the cavities created by perforation are completely filled by the material of the active substance reservoir 5, which also forms the active substance delivery sections 2 here, so that active substance delivery surfaces 2 and skin adhesion sections 1 alternate at the same level on the skin contact surface.
  • FIG. 6 shows a plaster-like embodiment of principle A, with individual active substance delivery surfaces 13 being symmetrically distributed according to the invention as circular points in the central region of an otherwise pressure-sensitive plaster-like section.
  • a circumferential, uninterrupted adhesive adhesive edge 12 is provided which, when the plaster is applied, ensures secure edge adhesion to the skin.
  • FIGS. 3 and 4 represent preferred embodiments of principle B.
  • an active ingredient delivery surface 8 is interrupted by symmetrically arranged hexagonal skin adhesion sections 7.
  • the arrangement of the adhesive areas, the spacing from one another, their size and their geometric shape are variable and can be modified in accordance with manufacturing requirements.
  • the structure of the system seen from the skin contact surface in FIG. 3 is evident from the greatly enlarged cross section shown in FIG. 4 along the line II-II.
  • a backing layer 9 adjoins an adhesion-limiting intermediate layer 10, which in turn is in contact with a reservoir layer 11.
  • Skin adhesion points 7, which are flush with the surface of the active substance reservoir 8 towards the skin, are embedded in the reservoir layer 11 to a certain extent
  • the adhesive dots 7 are surrounded all around by the active ingredient delivery surface 8.
  • FIG. 5 shows a further exemplary embodiment of Principle B of the invention, in the form of an application-ready plaster-shaped section.
  • the skin adhesion sections are denoted by 12 and the active substance delivery surfaces by 13.
  • the active substance release surface is symmetrically interspersed with square skin adhesion points and is surrounded on all sides by a circumferential skin adhesion edge.
  • edge sticking problems of the plaster-like systems according to the invention can be avoided.
  • the application possibilities of the new sheet-like therapeutic systems according to the invention are very variable, since - apart from special embodiments, as are shown, for example, in FIGS. 5 and 6 - they are produced as repeat-free web goods and can therefore be divided into almost any desired cuts .
  • the application can take the form of a plaster, strip or even a bandage. If the webs are cut arbitrarily, it is possible for cut edges to arise which are not completely covered with pressure-sensitive adhesive. It should therefore preferably be ensured that the cutting lines always lead through such adhesive strips, rings or the like.
  • the skin-adhesive material-free sections can be kept so small by a suitable choice of the geometric design of the system that, even when the plaster is worn for a long time, there is no detachment from the edge.
  • the area of the tolerable sections free of skin adhesion material depends on the choice of skin adhesion material.
  • a special case in this context is a therapeutic system in which the active substance delivery surface is distributed in strips in the skin adhesion surface or the skin adhesion surface is distributed in strips in an active substance delivery surface.
  • the cut may only lie parallel to the direction of the strip within a pressure-sensitive adhesive strip, in order to avoid an edge that is completely tack-free in this direction.
  • the new system is particularly suitable for the administration to the skin of medical or cosmetic active ingredients which cannot be applied, or can only be applied with difficulty, from systems containing pressure-sensitive adhesives.
  • all active substances that are easy to apply can also be used, which can migrate into the skin alone or with aids.
  • the active substance reservoir layer can be produced in a manner known per se, for example by dissolving the active substance in a matrix, dispersing the active substance in a matrix or distributing the active substance in a matrix in microencapsulated form; Distribution of the active ingredient adsorbed on an inert carrier in a matrix.
  • the active substance reservoir can also consist of pure active substance or essentially pure active substance
  • the matrix itself can consist of low or high molecular weight, natural or synthetic substances.
  • ⁇ hen while their selection depends on the properties of the active ingredient to be administered and the therapeutic requirements, as are known to those skilled in the art.
  • a matrix based on water-swellable polyacrylates has proven particularly useful.
  • the active ingredient reservoir layer can contain other suitable additives known to the person skilled in the art on the basis of his specialist knowledge, such as, for example, solubilizers, plasticizers, stabilizers, fillers and enhancers.
  • the thickness of the reservoir layer ie the distance between the support layer and possibly the backing layer which is provided with adhesive, is mainly determined by the therapeutic requirements on the system; it is preferred that the total thickness of the system is between 40 mm and 5 mm, preferably between 80 ⁇ m and 1.2 mm.
  • the reservoir consists only of the complete or partial filling of the pore openings in the laminate from the support and skin adhesion layers, so that the pressure-sensitive adhesive backing is in direct contact with the support layer.
  • the active substance delivery surfaces lie in one plane with the skin adhesion surfaces, as is required according to the invention.
  • the backing layer covering the reservoir on the side facing away from the skin can be permeable or impermeable. It must be flexible and primarily serves to further mechanically stabilize the system. If parts of the reservoir or the incorporated active substances are volatile - the backing layer must be impermeable to these substances. It can be one or more layers. Substances that can be used in their manufacture are polymeric substances such as polyethylene, polypropylene, polyethylene terephthalate and polyamides. Metal foils, such as, for example, aluminum foil, alone or coated with a polymeric substrate, can also be used as further materials. Permeable backing layers are, for example, textile fabrics, such as fabrics and nonwovens, or also porous polymer materials.
  • the required thickness of the backing layer depends on the material chosen, but should be in the range of 5 to 150 micrometers, preferably between 10 and 60 are micrometers. If the inherent tackiness of the reservoir layer is not sufficient for a permanent bond with the backing layer, the bond is accomplished with the aid of a pressure-sensitive adhesive intermediate layer, the adhesive forces between the backing and intermediate layer having to be greater than that between the skin contact surface and the skin. In addition, all are physiologically harmless, opposite Active ingredients and other components of the reservoir are suitable for inert pressure-sensitive adhesives, for example based on rubber, rubber-like synthetic homopolymers, copolymers or block polymers, polyacrylic acid, esters and their copolymers, polyurethanes and silicones.
  • the thickness of the adhesive intermediate layer 10 is preferably between 10 and 100 ⁇ m and particularly preferably between 20 and 40 ⁇ m.
  • the adhesive layer is applied to a support layer which is in contact with the active substance reservoir. Arrangements without this support layer are of course possible and can be advantageous in the case of particularly durable active substance reservoir layers.
  • the support layer has openings, preferably through pores, which are up to. All or part of the skin contact area is filled with an active ingredient delivery mass. Suitable materials for this flexible support layer are, for example, paper, plastic and metal foils or textile fabrics.
  • the layer thickness should be between 5 ⁇ m and 2 mm, preferably between 10 ⁇ m and 500 ⁇ m.
  • a secure bond between the active substance reservoir and the support layer cannot be guaranteed by the inherent tackiness of the reservoir, it can be brought about by attaching an additional pressure-sensitive adhesive layer between the support material and the active substance reservoir layer, the adhesive forces within the overall system having to be greater than that between skin contact surface and skin.
  • the pressure-sensitive adhesive layer can cover the entire contact area between the active substance reservoir and the support layer or can be limited to the areas of the support layer that are parallel to the skin.
  • the pressure sensitive adhesive to be used must, like the pressure sensitive adhesive the intermediate layer between the reservoir and the back layer cause greater adhesion within the system than between the skin and the skin contact surface.
  • the thickness of this pressure-sensitive adhesive layer is preferably between 10 and 100 ⁇ m, particularly preferably between 20 and 40 ⁇ m.
  • the system according to the invention is covered on the skin contact side by a layer which can be removed before application. It can be made from the same materials as are used to produce the backing layer, provided that they are made removable, for example by applying a silicone layer.
  • Other removable protective layers are, for example, polytetrafluoroethylene, treated paper, cellophane, polyvinyl chloride and the like.
  • the protective layer can be provided with removal aids in a manner known per se.
  • the thickness of the protective layer is not essential since it does not affect the wearing comfort because of the removal before the application. It can usefully be between 10 and 500 ⁇ m, preferably between 20 and 150 ⁇ m; but it can also be very stiff - in order to avoid kinking of the system before application.
  • the method according to the invention for producing the new therapeutic system is a combination of known method steps.
  • the laminate obtained in this way is then perforated using known methods, for example by punching or with the aid of a spiked or anilox roller, the geometrically desired openings being able to be determined by the choice of the tool.
  • the support and adhesive layers are perforated in any case and the repellent base is embossed or even perforated. The latter is removed in a further step and replaced by the removable protective layer.
  • the active substance reservoir layer is then applied to the perforated skin adhesion layer side of the laminate in a manner known per se.
  • the solvent must be evaporated off before further process steps.
  • the consistency of the mass applied to the active substance reservoir is initially set so that it is completely penetrated into the openings of the laminate.
  • the system is completed by laminating on a backing layer which may have been provided with a pressure-sensitive adhesive layer (corresponds to the intermediate layer).
  • the web material obtained in this way can now, as described above, be prepared and packaged taking into account therapeutic requirements.
  • a preferred further development of this method consists in that the active substance reservoir layer is produced on a back layer — optionally provided with a pressure-sensitive adhesive layer — and by laminating under pressure or under pressure and heat to an laminate having openings Support layer and skin adhesion layer is applied.
  • the auxiliary layer is then removed again before the reservoir layer is applied or laminated on.
  • the manufacturing process is modified insofar as in the first step the support material is one-sided (for example by spraying) or all-round (for example by dipping) with a pressure sensitive adhesive coating and is placed on the removable protective layer.
  • the further process steps correspond to those described above after the perforation, it being possible to dispense with an exchange of the repellent base.
  • Flat therapeutic systems according to principle A without a support material layer can be produced by producing the active substance application surfaces in the desired arrangement, for example using a screen printing method, on a protective layer, coating them with pressure-sensitive adhesive and covering them with the backing layer.
  • FIGS. 5 and 6 The preferred embodiments of the system according to the invention shown in FIGS. 5 and 6. can also be produced by the described methods; In the case of plasters according to FIG. 5, only the device applying the skin adhesive material (for example screen printing stencil) has to be designed accordingly, whereas in the case of plasters according to FIG. 6 the perforation tool has to be structured accordingly. In both cases, the specified repeat must be observed when assembling.
  • the skin adhesive material for example screen printing stencil
  • Anilox roller is designed as follows: staggered rows of truncated pyramids at a clear distance of 2 mm; lights
  • Silicone paper is peeled off and a siliconized
  • polyester film (basis weight: 145 g / m) let run in.
  • the viscosity of the mass is adjusted to 0.55 dPa.s with methyl ethyl ketone.
  • Bulk order on the non-stick side of the perforated manufactured above Nonwoven laminates are made by means of a roller in a layer thickness so that after drying at 65 degrees C. a reservoir layer of 44 g / m is obtained.
  • the pressure-sensitive backing layer is coated by coating a siliconized paper with an acrylate-copoly er solution (DUROTAK 280 - 2416, National Starch s-Chemical B.V., Netherlands) in ethyl acetate
  • the patch sections are punched out of the web material obtained in such a way that their size corresponds to the therapeutic requirements.
  • a punching aid for the protective layer can be created by punching the protective layer over a corner.
  • the packaging can take place, for example, in suitable sealing bags.
  • the therapeutic system is produced analogously to Example 1, except for the production and composition of the active substance reservoir mass. It is made here by dissolving 30.6 parts by weight of a methacrylic acid ester / dimethylaminoethyl methacrylate copolymer (EUDRAGIT E, Röhm " Pharma, FRG), dissolved in 30.6 parts by weight of tetrahydrofuran, addition of 25 parts by weight of ⁇ ) -l- (tert-butylamino) -3- (2-methyl-1H-in-dol-4-yl ) oxy -2-pr-opanol-benzoate-hydrogen malonate (bopindolol-HMO), 3.75 parts by weight of malonic acid and 10 parts by weight of 2-octyl-dodecanol and adjusting the viscosity to 0.55 dPa.s using methyl ethyl ketone.
  • EUDRAGIT E dimethylaminoethyl methacrylate
  • 2 manufactured web goods is reinforced as a therapeutic system with a single-sided # living plastic film on the back layer and in each case in a vessel at 37 degrees C. exposed to an acceptor medium (80 ml of physiological saline solution), so that close contact with the vessel walls is avoided and the Release page is constantly completely wetted.
  • the acceptor medium is renewed after 2, 4, 8 and 24 hours after the insertion of the diecut into the physiological saline solution.
  • the quantitative determination of the released active ingredients is done photometrically.
  • the ketotifen HFU concentration is determined by measuring the UV absorption at 265 nm and in the case of bopindolol HMU by measuring the UV absorption at 265 nm.
  • Example 1 Coating the product by roller application, the ketotifen-containing reservoir mass described in Example 1 is applied. The process is continued as in Example 1.
  • Example 3 Production of a bopindolol system according to principle B of the invention: As described in Example 3, a therapeutic system according to the invention is produced, the active substance reservoir composition described in Example 2 being applied.
  • An active ingredient-containing system is produced as described in Example 4, lanata- ⁇ -acetyldigoxin being used as the reservoir mass in the acrylate system and nitroglycerin in the skin adhesion section.

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  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Le système décrit comporte une couche extérieure souple (3), un ou plusieurs réservoirs de principes actifs (5), une ou plusieurs couches (4) auto-adhésives et éventuellement une couche de protection amovible pour la surface de contact dudit système avec la peau, cette surface de contact étant une couche de contact dermique qui possède une ou plusieurs sections (2) non adhésives de dégagement de principes actifs et une ou plusieurs sections (1) d'adhérence dermique comprenant éventuellement un autre principe actif. Sont également décrits un procédé de fabrication du système planiforme ainsi que son utilisation en médecine humaine ou vétérinaire ou en cosmétique pour l'administration transdermique topique ou systémique de principes actifs.
PCT/DE1987/000174 1986-04-17 1987-04-16 Systeme therapeutique planiforme, son procede de fabrication et son utilisation WO1987006144A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
HU872359A HU203842B (en) 1986-04-17 1987-04-16 Method for producing single-plane therapy system
KR1019870701189A KR900007178B1 (ko) 1986-04-17 1987-04-16 피부 약제 처치용 치료제의 제법
NO875144A NO171951C (no) 1986-04-17 1987-12-09 Anordning for tilfoering av virksomme stoffer til huden
DK662887A DK170434B1 (da) 1986-04-17 1987-12-16 Fladeformigt terapeutisk system, fremgangsmåder til fremstilling deraf og anvendelse deraf

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DEP3613002.8 1986-04-17
DE3613002 1986-04-17
DE19863634016 DE3634016A1 (de) 1986-04-17 1986-10-06 Flaechenfoermiges therapeutisches system, verfahren zu seiner herstellung und seine verwendung
DEP3634016.2 1986-10-06

Publications (1)

Publication Number Publication Date
WO1987006144A1 true WO1987006144A1 (fr) 1987-10-22

Family

ID=25842978

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Application Number Title Priority Date Filing Date
PCT/DE1987/000174 WO1987006144A1 (fr) 1986-04-17 1987-04-16 Systeme therapeutique planiforme, son procede de fabrication et son utilisation

Country Status (21)

Country Link
US (1) US5132115A (fr)
EP (1) EP0242827B1 (fr)
JP (1) JP2542026B2 (fr)
KR (1) KR900007178B1 (fr)
AU (1) AU608223B2 (fr)
CA (1) CA1301005C (fr)
CZ (1) CZ284976B6 (fr)
DE (2) DE3634016A1 (fr)
DK (1) DK170434B1 (fr)
ES (1) ES2055692T3 (fr)
FI (1) FI89243C (fr)
GR (1) GR3003570T3 (fr)
HU (1) HU203842B (fr)
IE (1) IE59729B1 (fr)
IL (1) IL82192A (fr)
NZ (1) NZ220016A (fr)
PL (1) PL155408B1 (fr)
PT (1) PT84674B (fr)
SK (1) SK279947B6 (fr)
WO (1) WO1987006144A1 (fr)
YU (1) YU47135B (fr)

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US5352457A (en) * 1990-10-05 1994-10-04 Ethical Pharmaceuticals Limited Transdermal device
FR2719770A1 (fr) * 1994-05-11 1995-11-17 Lhd Lab Hygiene Dietetique Système matriciel pour administration transdermique d'ibuprofène et procédé de préparation.
DE19912477A1 (de) * 1999-03-19 2000-09-28 Lohmann Therapie Syst Lts Transdermales therapeutisches System und Verfahren zu seiner Herstellung

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Publication number Priority date Publication date Assignee Title
US5352457A (en) * 1990-10-05 1994-10-04 Ethical Pharmaceuticals Limited Transdermal device
FR2719770A1 (fr) * 1994-05-11 1995-11-17 Lhd Lab Hygiene Dietetique Système matriciel pour administration transdermique d'ibuprofène et procédé de préparation.
WO1995031193A1 (fr) * 1994-05-11 1995-11-23 Laboratoires D'hygiene Et De Dietetique Systeme matriciel pour administration transdermique d'ibuprofene et procede de preparation
DE19912477A1 (de) * 1999-03-19 2000-09-28 Lohmann Therapie Syst Lts Transdermales therapeutisches System und Verfahren zu seiner Herstellung

Also Published As

Publication number Publication date
FI871399A0 (fi) 1987-03-31
DE3634016A1 (de) 1987-10-29
EP0242827A1 (fr) 1987-10-28
YU47135B (sh) 1995-01-31
PT84674B (pt) 1989-11-30
ES2055692T3 (es) 1994-09-01
IL82192A (en) 1992-09-06
EP0242827B1 (fr) 1991-12-27
US5132115A (en) 1992-07-21
KR900007178B1 (ko) 1990-09-29
JP2542026B2 (ja) 1996-10-09
CZ268587A3 (cs) 1998-12-16
YU67987A (en) 1989-10-31
DE3634016C2 (fr) 1992-04-09
DK662887A (da) 1987-12-16
SK268587A3 (en) 1999-06-11
HUT46548A (en) 1988-11-28
AU608223B2 (en) 1991-03-28
FI871399A7 (fi) 1987-10-18
DE3775449D1 (de) 1992-02-06
CA1301005C (fr) 1992-05-19
IE870963L (en) 1987-10-17
IE59729B1 (en) 1994-03-23
IL82192A0 (en) 1987-10-30
FI89243C (fi) 1993-09-10
DK170434B1 (da) 1995-09-04
NZ220016A (en) 1990-03-27
SK279947B6 (sk) 1999-06-11
CZ284976B6 (cs) 1999-04-14
DK662887D0 (da) 1987-12-16
PL155408B1 (en) 1991-11-29
PL265181A1 (en) 1988-07-21
JPH01500115A (ja) 1989-01-19
PT84674A (en) 1987-05-01
AU7283287A (en) 1987-11-09
HU203842B (en) 1991-10-28
GR3003570T3 (fr) 1993-03-16
KR880701119A (ko) 1988-07-25
FI89243B (fi) 1993-05-31

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